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IRCT20250207064679N1 IRCT 2025-09-19 Yasouj University of Medical Sciences The effect of vitamin D and synbiotics consumption on sexual function and sexual self-expression in lactating women Evaluation the effect of combination use of synbiotics and vitamin D compared to their separate use on sexual function and sexual self-expression in lactating women: A randomized double blind clinical trial 2025-11-21 anticipated 112 Complete https://irct.ir/trial/81827 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Individuals who meet the eligibility criteria for participation in the study will be assigned to the intervention groups. A block randomization method will be used to assign individuals to the study groups. The advantages of blocked randomization are that the balance of the number of patients in each group is guaranteed. The groups are defined as codes A, B, C. Group (A) receiving vitamin D 2. Group (B) receiving synbiotics 3. Group (C) receiving simultaneous consumption of vitamin D and synbiotics Before assigning individuals to one of the groups, a list of letters (A, B, C) in the form of blocks is formed. This random assignment list will be formed by the reliable website https://www.sealedenvelope.com. Each of the referring and eligible individuals will be assigned to one of the groups according to the created list. To prevent the predictable risk of assigning individuals to different groups, blocks of different sizes (3, 6, and 9) will be created. Triple blocks like ACB – Six-blocks like ABBCAD – Nine-blocks like DBCADACBA, Blinding description: This study will be double-blinded, meaning that neither the participants nor the researcher will know which intervention each person is receiving. The purpose of this method is to control bias. Double-blinding means that neither the participants nor the principal investigators and data collectors will be aware of the assigned group (synbiotic and vitamin D group simultaneously, separate group + placebo). To ensure complete and effective blinding, the following measures will be taken: * Supplement/placebo packaging and coding: - Synbiotic, vitamin D, and placebo supplements will be prepared and packaged by an independent individual outside the research team. To maintain the blinding structure in the study, the placebos used in this study will be prepared and formulated by the Drug Manufacturing Center of the Faculty of Pharmacy, Yasuj University of Medical Sciences. These placebos are made in the form of capsules without active ingredient but of the same shape, color and weight as the original supplements so that there is no possibility of differentiation by the participant or the researcher. In groups where only one of the supplements (vitamin D or synbiotic) is received, the second supplement will be replaced with placebo; so that all participants in all three groups will receive two capsules daily (one real supplement and one placebo or two real supplements). In this way, the double-blind structure and balance in the way of consumption are maintained. - All packages (both supplement and placebo) will have the same shape, color, taste, smell and appearance so that they are not physically distinguishable. - Each package will be labeled with a unique numeric or alphanumeric code, the meaning of which (which group it belongs to) is known only by the independent coder. - The coding list will remain confidential until the completion of data collection and initial statistical analysis and will only be opened in case of emergency (e.g. serious complications in the participant) or after the end of the study. * Distribution and monitoring: - Distribution of supplements/placebo to participants will be carried out by a person who is not part of the main research team and is unaware of the group allocation. - Follow-up procedures will be carried out to ensure correct and regular intake of supplements/placebo (e.g. counting remaining pills at subsequent visits), without providing information about the type of supplement to the participant or the data collector. * Data collection and analysis: - Data collectors who interact with participants will have no knowledge of the group allocation of participants. - The statistical analyst will also receive data based on blinded codes and will be unaware of the nature of groups A, B, and C until the end of the initial analysis. 3 Condition 1: sexual function. Condition 2: sexual self-expression. Intervention 1: First intervention group: receiving vitamin D supplement (one capsule of 1000 international units, made in Iran or imported, depending on availability and approval by the Food and Drug Administration/daily for 8 weeks) and placebo, daily Lactofem supplement. Intervention 2: Second intervention group: Recipient of Lactofem supplement manufactured by Zist Takhimr Company. One tablet daily for 8 weeks) and placebo vitamin D supplement 1000. Intervention 3: Third intervention group: Simultaneously receiving vitamin D and lactofem supplement (one of each drug daily according to the same schedule). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no information.
public Maryam Naeemi
Somayeh Girls' Dormitory, Sahely Street, towards Emam Sajjad Hospital.
yasuj Iran (Islamic Republic of) 7591994834 +98 74 3322 1308 matyam99774411@gmail.com Yasouj University of Medical Sciences scientific Mahboobeh Sharifi
Yasuj University of Medical Sciences Headquarters, Shahid Motahari Blvd., Yasuj
yasuj Iran (Islamic Republic of) 7591741417 009833337230 msharifi75@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) - Age between 18 and 40 years - At least 1 month has passed since the start of sexual intercourse and a maximum of 4 months after childbirth (before the start of complementary feeding) - Active and exclusive breastfeeding - Having sex at least once a month - No history of chronic diseases (diabetes, thyroid, epilepsy, etc.) - No use of hormonal or antidepressant medications in the past 3 months - Consent to participate in the study and completion of the informed consent form 18 years 40 years Female - Allergy to prescribed supplements - Taking medications that affect sexual function and self-expression, such as blood pressure reducers, antihistamines, H2 blockers, barbiturates - Taking birth control pills - Taking supplements containing synbiotics, probiotics, or vitamin D (except for the usual doses of pregnancy supplements if taken continuously during pregnancy and no more) for at least 4-6 weeks prior - Taking any new medications that affect mood or sexual function Prevention Prevention Prevention First intervention group: receiving vitamin D supplement (one capsule of 1000 international units, made in Iran or imported, depending on availability and approval by the Food and Drug Administration/daily for 8 weeks) and placebo, daily Lactofem supplement Second intervention group: Recipient of Lactofem supplement manufactured by Zist Takhimr Company. One tablet daily for 8 weeks) and placebo vitamin D supplement 1000 Third intervention group: Simultaneously receiving vitamin D and lactofem supplement (one of each drug daily according to the same schedule) Sexual function of lactating women. Timepoint: At the beginning of the study and 8 weeks after starting the supplements. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Sexual self-expression of lactating women. Timepoint: At the beginning of the study and 8 weeks after starting the supplements. Method of measurement: Hulbert Index of Sexual Assertiveness questionnaire. Yasouj University of Medical Sciences Approved 2025-09-04 Ethics committee of Yasuj University of Medical Sciences Somayeh Girls' Dormitory, Sahely Street, towards Emam Sajjad Hospital. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)